Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2025-12-24 @ 4:06 PM
Study NCT ID:
NCT03901066
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2019-03-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smoking Dependence and Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of nicotine dependence level on periodontal outcomes', 'timeFrame': '1 day', 'description': 'effect of nicotine dependence score on pocket depth (PD)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking', 'Periodontitis']}, 'descriptionModule': {'briefSummary': 'The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis', 'detailedDescription': 'The present study was designed as a, single-center, prospective cohort study focusing on the relationship between smoking status and the severity of periodontitis.\n\nThe research question was " How the Fagerström for nicotine dependence (FTND) and the number of cigarette cunsuption (NNC) are correlated to the severity of chronic periodontitis"? Thirty-four consecutive smoker patients presenting a chronic periodontitis were included in the study, and the smoking status was defined both by NCC and FTND.\n\nPeriodontal clinical parameters were correlated with NCC and FTND.\n\nAll the clinical periodontal parameters were recorded by a single periodontist (L.S). Periodontal assessments included: probing depth (PD), gingival recession (RD), clinical attachment level (CAL), bleeding on probing (BOP), plaque score index (PI), Furcation (Furc), tooth mobility and the percentage of sites of PD ≥ 6mm. A graduated manual periodontal probe was used to take measurements at the 6 sites of each tooth. BOP (%) and plaque score (%).\n\nAll the participants of the study respected the following inclusion criteria: 1/ smoker patients aged of minimum 18 years old, 2/ chronic periodontitis, 3/ presence of a minimum of 6 teeth at each arch, 4/ a minimum of 6 teeth with pocket depth of 5 mm, 5/ signed the informed consent. The exclusion criteria were: 1/ aggressive periodontitis, 2/ diabetes, 3/ connective tissue disease, 4/ pregnancy, 5/ radio-therapy, 6/ chemotherapy, 7/ psychological disease, 8/ previous periodontal therapy.\n\nThe patient smoking status was defined by FTND and NCC FTND scores were categorized in 3 groups\n\n* scores \\< 4 for low nicotine dependence,\n* scores = 4-5 for moderate nicotine dependence\n* scores \\> 5 for high nicotine dependence.\n\nThe NCC s was classified in three levels of smokers as described in most of the periodontal studies:\n\n* Number of cigarette smoking ≤ 10 per day for low consumption\n* Number of cigarette smoking from 10 to 20 per day for moderate consumption\n* Number of cigarette smoking \\> 20 per day for high cigarette consumption'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '34 consecutive smoker patients presenting periodontitis were included from the Department of Periodontology and Oral Surgery at the University of Liege, Belgium. All the participants of the study respected the aboveinclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoker patients aged of minimum 18 years old\n* chronic periodontitis\n* presence of a minimum of 6 teeth at each arch\n* a minimum of 6 teeth with pocket depth of 5 mm\n* signed the informed consent\n\nExclusion Criteria:\n\n* aggressive periodontitis\n* diabetes\n* connective tissue disease\n* pregnancy\n* radio-therapy\n* chemotherapy\n* psychological disease\n* previous periodontal therapy.'}, 'identificationModule': {'nctId': 'NCT03901066', 'briefTitle': 'Smoking Dependence and Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Smoking Dependence (Fagerström) as a Relevant Indicator for Tobacco Related Studies in Periodontology.', 'orgStudyIdInfo': {'id': 'File number: B707201419816'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'periodontist, PhD student', 'investigatorFullName': 'Leila Salhi', 'investigatorAffiliation': 'University of Liege'}}}}